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Dosage form: & nbspcoated tablets
Composition:(per one tablet)
Active substances
The belladonna the sum of alkaloids - 0.0001 grams
(in terms of 100% of the substance)
Phenobarbital - 0.0200 g
Ergotamine tartrate - 0.0003 g
(in terms of 100% of the substance)
Excipients (core):
Sucrose - 0.0535 g
(refined sugar or granulated sugar)
Potato starch - 0.0244 g
in terms of 97% of the substance
Povidone - 0.0007 g
(polyvinylpyrrolidone) low molecular weight medical 12600 ± 2700
Calcium stearate - 0.0 010 g
The mass of the core of the tablet is 0.1 g
Auxiliary substances (shell):
Sucrose - 0.0605831 g
(refined sugar or granulated sugar)
Silicon dioxide colloid - 0,000620 g
(Aerosil A-380)
Magnesium hydroxycarbonate 0.010900 g
(magnesium carbonate basic)
Titanium dioxide - 0.000620 g
(titanium dioxide)
Gelatin - 0.000274 g
Beeswax - 0.000030 g
Tropeoline 0 - 0.0000029 g
The weight of the coated tablet is 0.173 g
Description:

The tablets covered with a cover of light yellow color, biconcave form.

Pharmacotherapeutic group:Sedative remedy
ATX: & nbsp
  • Barbiturates in combination with other drugs
  • Pharmacodynamics:

    Bellataminal ® is a combined preparation. Has α-adrenoblocking, m-holinoblokiruyuschee and sedative effect, has antispasmodic properties. The drug reduces the excitability of central and peripheral adrenergic and cholinergic systems of the body,has a calming effect on the central nervous system (CNS), has some antispasmodic effect.

    Pharmacological properties of the drug are due to the action of the components that make up its composition.

    The belladonna the sum of alkaloids (alkaloids group atropine) has m-anticholinergic and spasmolytic effects. Prevents the stimulating effect of acetylcholine; reduces the secretion of salivary, gastric, bronchial, lacrimal, sweat glands, exocrine function of the pancreas. Reduces the muscle tone of the gastrointestinal tract, bile ducts and gallbladder, but increases the tone of the sphincters; causes tachycardia, improves the atrioventricular conductivity. It dilates the pupils, hinders the outflow of the intraocular fluid, increases the intraocular pressure, causes paralysis of accommodation, etc.

    Phenobarbital refers to the barbiturate group. It interacts with the barbiturate site of the benzodiazepine-γ-aminobutyric acid-receptor complex, thereby increasing the sensitivity of γ-aminobutyric acid receptors to γ-aminobutyric acid, opening the neuronal channels for chloride ions, which leads to an increase in their entry into the cell.

    Suppresses the sensory areas of the cerebral cortex, reduces motor activity, depresses the cerebral functions, including the respiratory center. Reduces the tone of the smooth muscles of the gastrointestinal tract. Has a sedative effect.

    Ergotamine ergot alkaloid. Affects various organs and systems of the body, incl. on the central nervous system; increases the tone of the uterus. It has been established that ergotamine is characterized by α-adrenoblocking activity in combination with a pronounced direct vasoconstrictor effect on the smooth musculature of peripheral vessels and cerebral vessels. In this regard, against the background of the action of ergotamine, in spite of its α-adrenoblocking activity, a tonic effect on the peripheral vessels and vessels of the brain predominates. It has a direct stimulating effect on the smooth muscles of the vessels of the skull, causing their narrowing due to binding to 5-HT1-serotonin receptors, which leads to their activation.

    Pharmacokinetics:

    Pharmacokinetic studies of the combined preparation were not conducted.

    The belladonna the sum of alkaloids contains a complex of biologically active substances, in connection with which the carrying out of pharmacokinetic studies is not possible.

    Phenobarbital when taken completely, but relatively slowly absorbed. The maximum concentration in the blood is observed 1-2 hours after administration. About 50% binds to plasma proteins. Phenobarbital evenly distributed in different organs and tissues; smaller concentrations are found in the brain tissues.

    Metabolized in the liver, induces microsomal liver enzymes: isoenzymes CYP3A4, CYP3A5, CYP3A7 (the rate of enzymatic reactions increases 10-12 times), increases the detoxification function of the liver.

    Cumulates in the body. The half-life (T1 / 2) is 2-4 days.

    It is excreted by the kidneys in the form of glucuronide, 25% - unchanged. Well penetrates into breast milk and through the placental barrier.

    Ergotamine after ingestion is slightly absorbed from the gastrointestinal tract. Bioavailability is low due to intensive metabolism during the "first passage" through the liver. The maximum concentration of ergotamine in the blood plasma is reached after 50-70 minutes after oral administration, 90% of ergotamine is metabolized in the liver. T1 / 2 is 2 hours. Major metabolites (some of them are active) are secreted with bile.About 4% is excreted with the kidneys unchanged.

    Indications:

    In the complex therapy of vegetative-vascular dystonia, accompanied by increased irritability, insomnia, headache, including with climacteric syndrome; to relieve itching with neurodermatitis.

    Contraindications:

    Hypersensitivity to the components of the drug. Angina pectoris and other severe manifestations of atherosclerosis, spasm of peripheral arteries, closed angle glaucoma, pregnancy, breastfeeding, childbirth, age of 18 years.

    Dosing and Administration:

    The drug is released by prescription. Inside 1 tablet 2-3 times a day after meals. The duration of the drug is from 2 to 4 weeks. It is possible to conduct repeated courses of treatment after consulting a doctor.

    Side effects:

    Allergic reactions, dry mouth, drowsiness, paresis of accommodation.

    Overdose:

    Symptoms of overdose: dizziness, lethargy, drowsiness, tachycardia, dilated pupils, discomfort, difficulty urinating, intestinal atony, convulsions, in severe cases, stupor, coma.

    First aid: gastric lavage, reception of activated charcoal, symptomatic therapy.

    Interaction:

    The effect of the drug is enhanced by alpha and beta adrenostimulators, nicotine.

    Special instructions:

    Do not use the drug for more than 4 weeks without a doctor's recommendation because of the risk of developing drug dependence on phenobarbital.

    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention, speed of psychomotor reactions.

    Form release / dosage:The tablets covered with a cover.
    Packaging:

    For 10, 30 or 50 tablets in a planar cell package. 3, 5 contour cell packs No. 10 or 1 outline cell packing No. 30 or No. 50 together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    In a dry place, at a temperature of no higher than 25 ° C. List B.

    Keep out of the reach of children.

    Shelf life:

    5 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001203 / 01
    Date of registration:16.01.2009 / 18.05.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:FARMTSENTR VILAR, ZAO FARMTSENTR VILAR, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.01.2017
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